Bone Screws

Cortical Bone Screw - Flattened Head Dia. 4,5 mm L 24 mm

Registry build 21.09.26
9manufacturers in China registered for this device type
29catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PHX
Manufacturer City Province Registered as Device types
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Stryker Trauson (Changzhou) Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 3
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Arthrex (Shanghai) Co., Ltd. Shanghai Shanghai Exporter 38
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34
Changzhou Atomic HI-Tech Radiation Co., Ltd. Changzhou Jiangsu Contract manufacturer 8

Record

Regulatory record for Bone Screws
Listed by Limacorporate, Italy
FDA product code PHX
Device type Shoulder Prosthesis, Reverse Configuration
Device class Class 2
Regulation 21 CFR 888.3660
510(k) K210717
Record published 2021-07-29
Record revised 2025-02-06 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Bone Screws
Catalogue number Size Status
8432.15.028 Dia. 5 mm L. 28 mm In distribution
8431.15.024 Dia. 4,5mm L 24mm In distribution
8431.15.044 Dia. 4,5 mm L 44 mm In distribution
8432.15.052 Dia. 5 mm L. 52 mm In distribution
8432.15.020 Dia. 5 mm L. 20 mm In distribution
8432.15.022 Dia. 5 mm L. 22 mm In distribution
8432.15.018 Dia. 5 mm L. 18 mm In distribution
8432.15.050 Dia. 5 mm L. 50 mm In distribution
8432.15.032 Dia. 5 mm L. 32 mm In distribution
8432.15.040 Dia. 5 mm L. 40 mm In distribution
8432.15.036 Dia. 5 mm L. 36 mm In distribution
8431.15.028 Dia. 4,5 mm L 28 mm In distribution
8432.15.046 Dia. 5 mm L. 46 mm In distribution
8431.15.040 Dia. 4,5 mm L 40 mm In distribution
8431.15.032 Dia. 4,5 mm L 32 mm In distribution
8432.15.024 Dia. 5 mm L. 24 mm In distribution
8431.15.048 Dia. 4,5 mm L 48 mm In distribution
8432.15.048 Dia. 5 mm L. 48 mm In distribution
8432.15.044 Dia. 5 mm L. 44 mm In distribution
8432.15.034 Dia. 5 mm L. 34 mm In distribution
8431.15.052 Dia. 4,5 mm L 52 mm In distribution
8432.15.038 Dia. 5 mm L. 38 mm In distribution
8432.15.042 Dia. 5 mm L. 42 mm In distribution
8432.15.026 Dia. 5 mm L. 26 mm In distribution
8431.15.020 Dia. 4,5mm L 20mm In distribution
8431.15.018 Dia. 4,5mm L 18mm In distribution
8431.15.036 Dia. 4,5 mm L 36 mm In distribution
8432.15.030 Dia. 5 mm L. 30 mm In distribution
8431.15.022 Dia. 4,5mm L 22mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arthrex® Arthrex, Inc. 297
FX V135 Fx Shoulder Solutions SAS 131
Prima TT Glenoid Limacorporate 129
Shoulder Innovations Inset Reverse Total Shoulder Shoulder Innovations, Inc 124
Equinoxe Exactech, Inc. 123
Veritas rTSA restor3d, inc. 112
DJO Surgical Encore Medical, L.P. 109
R1 Reverse Shoulder System Catalyst Orthoscience Inc 100
Tornier Perform™ Humeral System Tornier Inc. 96
MSS – Monobloc stem Medacta International SA 92
SMR Shoulder Limacorporate 90
Humelock II Cemented Reversible Shoulder Fx Solutions 83

Showing 12 of 232. All products under Shoulder Prosthesis, Reverse Configuration

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer